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AzTrials

Carcinoma of the Cervix, Stage IVBPhase 3BEATccNCT03556839

Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix

A Phase 3 study testing Atezolizumab, Bevacizumab and Cisplatin/Carboplatin in people with Carcinoma of the Cervix, Stage IVB, run by Grupo Español de Investigación en Cáncer de Ovario at 72 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Carcinoma of the Cervix, Stage IVB
What is being tested?
Atezolizumab, Bevacizumab and Cisplatin/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
72 sitesin 8 countries
Study dates
25 Sep 2018to 31 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients must be ≥18 years of age.
  • Signed informed consent before any study-specific procedure
  • Able (in the investigator´s judgment) to comply with the study protocol
  • GOG/Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Life expectancy ≥3 months
  • Histologically- or cytologically-confirmed diagnosis of metastatic (stage IVB), persistent, or recurrent cervical cancer (histologies other than squamous cell, adenocarcinoma, or adenosquamous will be excluded) not amenable for curative treatment with surgery and/or radiation therapy. The inclusion of patients with adenocarcinoma histology will be capped to 20% of the whole study population.
Show all 23Show fewer
  • No prior systemic anti-cancer therapy for metastatic or recurrent disease.
  • Measureable disease by RECIST v1.1 criteria.
  • A tumor specimen is mandatory at study entry.
  • Adequate organ function:
  • Hemoglobin ≥9 g/dL ANC ≥1.5 × 109/L Lymphocyte count ≥0.5 × 109/L Platelet count ≥100 x 109/L
  • Adequate liver function:
  • Serum albumin ≥2.5 g/dL Total serum bilirubin ≤1.5 ×ULN AST and ALT ≤2.5 × upper limit normal (ULN) or ≤5 × ULN if tumor involvement (liver) is present
  • Adequate renal function:
  • Patients with serum creatinine <1.5 × ULN Urine dipstick for proteinuria <2+.
  • Adequate coagulation:
  • Blood coagulation parameters (PTT, PT/INR): PT such that international normalized ratio (INR) is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT <1.5 × ULN.
  • Negative Test Results for Hepatitis:
  • Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening.The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
  • Toxicities related to previous treatments must be recovered to < grade 2 (with the exception of alopecia).
  • Female participants must be postmenopausal (≥ 12 months of non-therapy-induced amenorrhoea) or surgically sterile (absence of ovaries and/or uterus, or who received therapeutic radiation to the pelvis) or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods that result in a failure rate of <1% per year during the whole treatment period of the study and for at least 5 months (if the last study dose contained atezolizumab) or 6 months (if the last study dose contained bevacizumab) after the last dose of study treatment.
  • Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception

Who cannot join

  • Disease that is suitable for local therapy administered with curative intent
  • Prior radiotherapy delivered using cobalt (rather than a linear accelerator)
  • Patients with Stage IVA not amendable to concurrent chemo-radiation as primary treatment will not be eligible.
  • Ongoing disease involving the bladder or rectum at screening/baseline
  • Evidence of abdominal free air
  • Bilateral hydronephrosis, unless it can be alleviated by ureteral stent(s) or percutaneous drainage
Show all 47Show fewer
  • Patients previously treated with chemotherapy except when used concurrently with radiation therapy. Patients who have received either concurrent paclitaxel with radiation therapy or carboplatin/paclitaxel as adjuvant therapy are ineligible for the study.
  • Prior treatment with any anti-VEGF drug, including bevacizumab, CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.
  • Patients with a concomitant malignancy other than non-melanoma skin cancer. Patients with a prior invasive malignancy (except non-melanoma skin cancer ) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy.
  • Known brain metastases or spinal cord compression. It is mandatory to perform a scan of the brain in cases of suspected brain metastases (CT or MRI) or spinal cord compression (MRI).
  • History or evidence, following a neurological examination, of central nervous system (CNS) disorders, unless properly treated with standard medical treatment,(e.g. uncontrolled epileptic seizures). History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
  • Patients with serious non-healing wound, ulcer, or bone fracture.
  • Acute intestinal obstruction or sub-occlusion episode in the last 6 months.
  • Active GI bleeding or GI ulcer
  • History of Crohn's disease or inflammatory bowel disease
  • Prior bowel resection ≤6 weeks preceding first study dose
  • History of diverticulitis requiring medical intervention
  • NCI CTCAE (version 5.0) grade ≥2 enteritis
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, Cycle 1.
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1.
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
  • Current or recent (within 10 days before the first dose of study drug) chronic daily treatment with aspirin (>325 mg/day), clopidogrel (>75 mg/day), or current or recent (within 10 days before first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
  • Patients with pre-existing Grade 2 or greater peripheral neuropathy.
  • History of any grade ≥3 venous thromboembolic event (VTE)
  • Patients with clinically significant cardiovascular disease.
  • Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal.
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
  • Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis or celiac disease.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis
  • Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
  • Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1
  • Known human immunodeficiency virus (HIV)
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study Influenza vaccination should be given during influenza season only
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Treatment with systemic immunostimulatory agents (including but not limited to IFNs, IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1 The use of corticosteroids is allowed as premedication for paclitaxel-based regimen. All patients should be premedicated prior to receiving chemotherapy (including with corticosteroids) according to the prescription information of paclitaxel and cisplatin/carboplatin and the institutional standard of care guidance.
  • Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Prior anti-cancer monoclonal antibody (mAb), prior chemotherapy, targeted small molecule therapy as first line treatment for the treatment of metastatic or recurrent cervical cancer.
  • Women that are breastfeeding or pregnant
  • Known hypersensitivity to bevacizumab, atezolizumab or any of theirs excipients (including Cremophor)
  • Demonstration of any other neurological or metabolic dysfunction, found upon physical examination or laboratory tests involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications
  • No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment.

Trial locations and contacts

72 sites in 8 countries.

72 sites in 8 countries

Spain19 sites

  • Hospital de la Vall d'Hebron

    Barcelona, Barcelona, 08035

  • H. Clínic Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Reina Sofía Cordoba

    Córdoba, Cordoba, 14004

  • Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

    Donostia / San Sebastian, Gipuzkoa, 20014

  • ICO Girona

    Girona, Girona, 17007

  • Intitut Català d' Oncolgia L' Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Complejo Hospitalario Regional de Málaga

    Málaga, Málaga, 29010

  • Hospital Clinico Universitario Virgen Arrixaca

    Murcia, Murcia, 30120

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Parc Taulí

    Sabadell, Barcelona, 08208

  • Hosptial Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, Santiago de Compostela, 15706

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Instituto Valenciano de Oncología

    Valencia, Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital Quirón de Valencia

    Valencia, 46010

  • Hospital Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

France17 sites

  • ICO Paul Papin

    Angers, 49055

  • CHU Jean Minjoz

    Besançon

  • Institut Bergonié

    Bordeaux

  • Centre François Baclesse

    Caen

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Léon Bérard

    Lyon

  • ICM Val d'Aurelle

    Montpellier

  • Hôpital Privé du Confluent S.A.S.

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Groupe Hospitalier Diaconesses-Croix Saint-Simon

    Paris

  • HEGP

    Paris

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre CARIO-HPCA

    Plérin

  • ICO Centre René Gauducheau

    Saint-Herblain

  • Hôpitaux Universitaires

    Strasbourg

  • Institut Claudius Régaud

    Toulouse

  • Gustave Roussy

    Villejuif

Other trials in France

Italy17 sites

  • Fondazione Del Piemonte Per L'Oncologia

    Candiolo

  • Azienda Ospedaliero-Universitaria Di Ferrara

    Ferrara

  • Ospedale Lecce 'Vito Fazzi'

    Lecce

  • ASST Lecco

    Lecco

  • Irst Irccs

    Meldola FC

  • Irccs S. Raffaele - Milano

    Milan

  • Istituto Europeo di Oncologia

    Milan

  • Ospedale San Gerardo

    Monza

  • Istituto Nazionale Tumori Di Napoli Irccs Pascale

    Naples

  • Istituto Oncologico Veneto (IOV) IRCCS

    Padova

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

  • AUSL Romagna - P.O. di Ravenna, Lugo, Faenza, Rimini e Cattolica

    Ravenna

  • Azienda Usl - Irccs Di Reggio Emilia

    Reggio Emilia

  • Policlinico Universitario A. Gemelli

    Roma

  • AOU Città della Salute e della Scienza di Torino, Presidio Sant'Anna

    Torino

  • Ospedale Ordine Mauriziano

    Torino

  • Azienda Sanitaria Universitaria Integrata Di Udine

    Udine

Other trials in Italy

Japan8 sites

  • Kurume University Hospital

    Fukuoka

  • Saitama medical university international medical center

    Hidaka

  • Hokkaido Cancer Center

    Hokkaido

  • Hyogo Cancer Center

    Hyōgo

  • Cancer Institute Hospital

    Kōtoku

  • Niigata University Medical & Dental Hospital

    Niigata

  • Shizuoka Cancer Center

    Shizuoka

  • Keio University Hospital

    Tokyo

Other trials in Japan

Sweden4 sites

  • Lindköping University Hospital

    Linköping

  • Skane University Hospital

    Lund

  • Karolinska University Hospital

    Stockholm

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

Norway3 sites

  • Haukeland University Hospital

    Bergen

  • Oslo University Hospital

    Oslo

  • University Hospital of North Norway

    Tromsø

Other trials in Norway

United States2 sites

  • Massey Cancer Center

    Richmond, Virginia, 980037

  • Willis Knighton Cancer Center

    Shreveport, Louisiana, 71103

Other trials in United States

Germany2 sites

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Helios-Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

About this study

Official title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix

The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

Read the detailed description

Given that both Vascular Endothelial Growth Factor (VEGF) and PD-L1 appear important in cervical cancer pathogenesis, this study is designed to test the hypothesis that breaking of immune tolerance by PD-1/PD-L1 blockade will enhance the efficacy of anti-VEGF therapy in the treatment of patients with metastatic , persistent or recurrent cervical cancer. There are several data suggesting that atezolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in ovarian cancer that tumor expression of VEGF is negatively correlated to the density of CD8+ TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells.

In addition to promoting tumor angiogenesis, there is increasing evidence that VEGF plays a role in cancer immune evasion through several different mechanisms. Indeed, emerging evidence suggests that the endothelium acts as a selective barrier, allowing certain T cell subsets, notably T regulatory (Treg) cells, to traffic more effectively into the tumor contributing to tumor immune tolerance. In addition, some experiments have shown that tumour hypoxia promotes the recruitment of regulatory T (T reg) cells through induction of expression of the chemokine CC-chemokine ligand 28 (CCL28), which, in turn, promotes tumour tolerance and angiogenesis.

Some immunosuppressive activities of VEGF, however, can be reversed by inhibition of VEGF signaling. Mice exposed to pathophysiologic levels of VEGF exhibited impaired dendritic cell function, which could be restored by blockade of VEGFR2.

In turn, the anti-tumor effect of angiogenesis blockade requires CD8+ T cells supporting the notion that VEGF-A do not simply promote tumor growth through angiogenesis. Thus, peripheral immune tolerance and angiogenesis programs seem closely connected and cooperating to sustain tumour growth.

In addition, there is evidence that anti-VEGF therapy and immunotherapy act synergistically. Motz et al have suggested that the combination of anti-VEGF-A antibody and immunotherapy with adoptive T cell transfer led to a superior infiltration of tumor-reactive T cells than any single approach. Indeed, in a murine melanoma model, VEGF blockade synergized with adoptive immunotherapy, as evidenced by improved anti-tumor activity, prolonged survival, and increased trafficking of T cells into tumors. These data are reminiscent of the additive benefit observed in patients by combining recombinant interferon-alpha therapy and bevacizumab, a recombinant, humanized therapeutic antibody directed against VEGF, for the treatment of metastatic renal cell carcinoma.

More evidence has come from a clinical study of subjects with melanoma combining the checkpoint inhibitor (anti-CTLA-4) ipilimumab and bevacizumab. In 46 patients, the combined therapy yielded a 19.6% objective response rate, stable disease in 13%. All responses were durable >6 months and median survival was 25.1 months, much prolonged compared to ipilimumab's expectation in metastatic melanoma. Activated vessel endothelium with extensive CD8+ T cell and macrophage cell infiltration was observed in post-treatment biopsies, as well as marked increases in CD4/CCR7/CD45ROm central memory cells in peripheral blood in the majority of patients.

Thus, an emerging paradigm supported by the data above is that angiogenesis and immune suppression are two facets of a linked biological program. Tumors seem to co-opt these existing mechanisms that are normally required to limit excessive inflammation and promote tissue recovery during infection or wound healing. The execution of this program sustains tumor growth and promotes immunologic tolerance. Because of the intimate relationship between angiogenesis and immunosuppression, it is thus expected that inhibiting both pathways will result in improved and more durable clinical benefit.

Being tested
Atezolizumab, Bevacizumab, Cisplatin/Carboplatin, Paclitaxel
Keywords
Cervix, Carcinoma, Atezolizumab
Medical subject headings
Uterine Cervical Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Intravenous Infusion

  • BevacizumabDrug

    Also called Avastin

    Intravenous Infusion

  • Cisplatin/CarboplatinDrug

    Intravenous Infusion

  • PaclitaxelDrug

    Intravenous Infusion

Study groups in NCT03556839
Study groupRoleWhat they receive
Arm AActive comparatorCisplatin 50mg/m2 or carboplatin AUC 5 + paclitaxel 175mg/m2+ bevacizumab 15mg/kg i.v D1 Q3W. Patients who achieve a complete response after ≥6 treatment cycles may be allowed to continue only on biologic therapy, namely bevacizumab, upon investigator discussion.
Receives: Drug: Bevacizumab; Drug: Cisplatin/Carboplatin; Drug: Paclitaxel
Arm BExperimentalcisplatin 50mg/m2 or carboplatin AUC 5 + paclitaxel 175mg/m2 + bevacizumab 15mg/kg + atezolizumab 1200mg i.v, D1 Q3W.Patients who achieve a complete response after ≥6 treatment cycles may be allowed to continue only on biologics therapy, namely bevacizumab plus atezolizumab, upon investigator discussion.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Cisplatin/Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

    Measured: 48 months

  2. Overall survival

    Time from the date of randomization to the date of death due to any cause

    Measured: 48 months

Secondary outcomes (6)

  1. Objective Response Rate

    Based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

    Measured: 48 months

  2. Duration of response

    Based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

    Measured: 48 months

  3. Incidence of Treatment-Emergent Adverse Events of combining atezolizumab to chemotherapy plus bevacizumab compared to cisplatin or carboplatin/paclitaxel (CP) plus bevacizumab.

    Incidence, nature and severity of adverse events (AEs) assessed by CTCAE version 5.0

    Measured: 48 months

  4. First subsequent therapy

    Time from randomization to first subsequent therapy or death due to any cause

    Measured: 48 months

  5. Progression-free survival 2

    Time from randomization to the second event of disease progression per radiological criteria, start of a new line of therapy, due to symptomatic deterioration or to death due to any cause

    Measured: 48 months

  6. Patient-reported outcomes (PROs) of function and health related quality of life (HR-QOL) associated with atezolizumab + CP + bevacizumab compared to bevacizumab + CP alone, as measured by the functional and GHS/ HRQoL scales of EORTC QLQ-C30

    Mean and mean changes from baseline score in patient function (role, physical) and GHS/HRQoL, by assessment timepoint and between treatment arms, as assessed by the functional and GHS/HRQoL scales of EORTC QLQ-C30.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start25 Sep 2018
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556839
Sponsor's protocol ID
ENGOT-Cx10 / BEATcc
Other IDs
2018-000367-83, ENGOT-Cx10, GEICO 68-C, JGOG1084, GOG-3030, 2024-514179-17-00, 2018
Acronym
BEATcc
Status last verified
Apr 2026
First submitted
18 May 2018
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Takekuma M, Nishio S, Yamaguchi S, Yunokawa M, Nishio H, Nishino K, Kurosaki A, Minobe S, Villacampa G, Oaknin A, Okamoto A. Atezolizumab, bevacizumab, and platinum chemotherapy in cervical cancer: results of Japanese population from BEATcc. J Gynecol Oncol. 2025 Nov;36(6):e116. doi: 10.3802/jgo.2025.36.e116. Epub 2025 May 19.

    PubMed 40968753

  • Oaknin A, Gladieff L, Martinez-Garcia J, Villacampa G, Takekuma M, De Giorgi U, Lindemann K, Woelber L, Colombo N, Duska L, Leary A, Godoy-Ortiz A, Nishio S, Angelergues A, Rubio MJ, Farinas-Madrid L, Yamaguchi S, Lorusso D, Ray-Coquard I, Manso L, Joly F, Alarcon J, Follana P, Romero I, Lebreton C, Perez-Fidalgo JA, Yunokawa M, Dahlstrand H, D'Hondt V, Randall LM; ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030 Investigators. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024 Jan 6;403(10421):31-43. doi: 10.1016/S0140-6736(23)02405-4. Epub 2023 Dec 1.

    PubMed 38048793

  • Grau JF, Farinas-Madrid L, Oaknin A. A randomized phase III trial of platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab versus platinum chemotherapy plus paclitaxel and bevacizumab in metastatic (stage IVB), persistent, or recurrent carcinoma of the cervix: the BEATcc study (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030). Int J Gynecol Cancer. 2020 Jan;30(1):139-143. doi: 10.1136/ijgc-2019-000880. Epub 2019 Oct 23.

    PubMed 31645423

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Bevacizumab and Cisplatin/Carboplatin in people with Carcinoma of the Cervix, Stage IVB, run by Grupo Español de Investigación en Cáncer de Ovario at 72 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Spain, France, Italy, Japan, Sweden and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556839, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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